US20160030042A1 - Surgical instruments including mems devices - Google Patents

Abstract

Surgical instruments are disclosed that are couplable to or have an end effector or a disposable loading unit with an end effector, and at least one micro-electromechanical system (MEMS) device operatively connected to the surgical instrument for at least one of sensing a condition, measuring a parameter and controlling the condition and/or parameter.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 60/375,495 and U.S. Provisional Application Ser. No. 60/375,496, both of which were filed on Apr. 25, 2002, and the entire disclosures of which are incorporated herein by reference.
BACKGROUND
• 1. Technical Field
• The present disclosure relates to surgical instruments and, more particularly to mechanical, electro-mechanical and energy based surgical instruments and systems.
• The present disclosure relates generally to surgical instruments and systems and, more specifically, to surgical stapler instruments and systems and energy based instruments and systems, having micro-electromechanical system (MEMS) devices for sensing, monitoring, controlling, measuring and/or regulating conditions and/or parameters associated with the performance of various surgical procedures.
• 2. Background of Related Art
• Surgical instruments used in open and minimally invasive surgery are limited in their ability to sense and/or control conditions and/or parameters and factors critical to effective operation. For example, conventional surgical instruments cannot measurably detect the amount of tissue positioned between tissue contacting surfaces of an end effector of the surgical instrument.
• Micro-electromechanical systems (MEMS) are integrated micro devices or systems combining electrical and mechanical components. They are fabricated using integrated circuitry (i.e., I.C.) batch processing techniques and can range in size from micrometers to millimeters. These micro-electromechanical systems sense, control and/or actuate on the micro scale, and function individually or in arrays to generate effects on the macro scale.
• In general, MEMS devices are complex systems which individually include one or more electrical systems and/or one or more micro-mechanical systems. The micro-mechanical systems are fabricated using many of the same fabrication techniques that have miniaturized electronic circuits and made mass production of silicon integrated circuit chips possible. In particular, MEMS devices include mechanical micro-structures, micro-sensors, micro-actuators and electronics integrated in the same environment (i.e., on a silicon chip) by using micro-fabrication technology. Micro-fabrication technology enables fabrication of large arrays of devices, which individually perform simple tasks but in combination can accomplish complicated functions.
• MEMS devices are advantageous for many reasons. In particular, MEMS devices can be so small that hundreds can be fit in the same space, which perform the same or many different functions, as compared to a single macro-device, which performs a single function. Moreover, using I.C. batch processing techniques, hundreds to thousands of these MEMS devices can be fabricated on a single silicon wafer. This mass production greatly reduces the price of individual devices. Thus, MEMS devices are relatively less expensive than their macro-world counterparts. In addition, cumbersome electrical components are typically not needed with MEMS devices, since the electronics can be placed directly on the MEMS device. This integration also has the advantage of picking up less electrical noise, thus improving the precision and sensitivity of sensors. As discussed above, MEMS devices provide some of the functionality of analytical instrumentation, but with vastly reduced cost, size, and power consumption, and an ability for real-time, in situ measurement.
• Examples of micro-electromechanical systems are disclosed in U.S. Pat. No. 6,127,811 to Shenoy et al.; U.S. Pat. No. 6,288,534 to Starkweather et al.; U.S. Pat. No. 6,092,422 to Binnig et al.; U.S. Patent Application No. US 2001/0020166 PCT filed Apr. 30, 1997; Microtechnology in Modern Health Careby P. Detemple, W. Ehrfeld, H. Freimuth, R. Pommersheim, and P. Wagler in Medical Device Technology, November 1998; and Microelectromechanical Systems (MEMS): Technology, Design and Applications, coordinator: Lee, Abraham, University of California, Los Angeles, Department of Engineering, Information Systems and Technical Management, Short Course Program, Engineering 823.53, May 19-22, 1997, the entire contents of each of which are incorporated herein by reference.
• Accordingly, a need exists for surgical instruments that can sense a multitude of parameters and factors, such as, for example, the distance between the tissue contacting surfaces of the surgical instrument. Such a surgical instrument can, according to the conditions sensed and/or measured, utilize, display, record and/or automatically control the position of the tissue contacting surfaces of the surgical instrument or alert a surgeon prior to operation of the surgical instrument.
• In view of the foregoing, the need exists for the use of micro-electromechanical systems in combination with the surgical instruments and systems and, in particular in stapling instruments and energy based surgical instruments for monitoring, controlling and regulating conditions and/or parameters associated with the performance of various mechanical, electro-mechanical and electrosurgical procedures.
SUMMARY
• The present invention is direct to surgical instruments including an end effector configured and adapted to engage tissue, and at least one micro-electromechanical system (MEMS) device operatively connected to the surgical instrument for at least one of sensing a condition, measuring a parameter and controlling the condition and/or parameter adjacent the end effector. The at least one MEMS device is operatively connected to the end effector. The at least one MEMS device is at least one of a pressure sensor, a strain sensor, a displacement sensor, an optical sensor, a biosensor, a temperature sensor, a torque sensor, an accelerometer, a flow sensor, an electrical sensor and a magnetic sensor for at least one of sensing, measuring and controlling the associated condition and/or parameter.
• It is contemplated that the surgical instrument is a surgical stapler and the end effector includes a staple cartridge assembly, and an anvil operatively associated with the staple cartridge, the staple cartridge and the anvil being movably connected to one another to bring one into juxtaposition relative to the other. Each of the staple cartridge and the anvil define tissue contacting surfaces and the at least one MEMS device is operatively connected to at least one of the tissue contacting surface of the staple cartridge and the tissue contacting surface of the anvil. A plurality of MEMS devices are connected to the surgical instrument, the MEMS devices being configured and adapted to measure distance between the tissue contacting surface of the staple cartridge assembly and the tissue contacting surface of the anvil.
• The MEMS devices can be configured and adapted to measure the amount of pressure applied to tissue clamped between the tissue contacting surface of the staple cartridge and the tissue contacting surface of the anvil. The MEMS devices are configured and adapted to measure the thickness of the tissue clamped between the tissue contacting surface of the staple cartridge and the tissue contacting surface of the anvil.
• It is envisioned that the end effector is configured and adapted to perform an anastomosis. The surgical instrument can be a linear stapler that is adapted to perform an endoscopic gastrointestinal anastomosis. It is further contemplated that the surgical instrument is an annular stapler that is adapted to perform an end-to-end anastomosis.
• It is envisioned that the end effector is a jaw mechanism including a pair of jaw members pivotably coupled to the distal end of the elongate shaft. It is further envisioned that at least one MEMS device is provided on at least one of the pair of jaw members. The MEMS devices are provided at least at one of a proximal end, a distal end and along a length of each of the pair of jaw members.
• It is envisioned that the jaw mechanism is configured and adapted to perform an electrosurgical function. The jaw mechanism is configured and adapted to deliver electrosurgical energy to a target surgical site.
• It is further envisioned that the surgical instrument is operatively couplable to a robotic system, wherein the end effector is configured and adapted to be remotely operated by the robotic system.
• It is contemplated that the surgical instrument can include a loading unit having a proximal end and a distal end, the proximal end being selectively removably connected to the surgical instrument, the end effector is operatively connected to and part of the loading unit, and the loading unit includes the at least one MEMS device.
• The end effector can be a surgical stapler including a staple cartridge assembly, and an anvil operatively associated with the staple cartridge assembly, the staple cartridge assembly and the anvil being movable and juxstaposable relative to one another. Each of the staple cartridge assembly and the anvil define tissue contacting surfaces and wherein at least one MEMS device is operatively connected to the at least one of the tissue contacting surface of the staple cartridge assembly and the tissue contacting surface of the anvil.
• The MEMS devices are configured and adapted to measure distance between the tissue contacting surface of the staple cartridge assembly and the tissue contacting surface of the anvil. The MEMS devices are configured and adapted to measure at least one of the amount of pressure applied to tissue and the thickness of tissue clamped between the tissue contacting surface of the staple cartridge assembly and the tissue contacting surface of the anvil.
• The loading unit can include an elongate shaft having a distal end, the end effector being operatively connected to a distal end of an elongate shaft and the staple cartridge and the anvil are oriented transversely with respect to the elongate shaft.
• It is envisioned that the end effector is configured and adapted to perform an anastomosis. It is further envisioned that the end effector is a jaw mechanism including a pair of jaw members pivotably coupled to the distal end of the elongate shaft. The at least one MEMS device is provided on at least one of the pair of jaw members. The MEMS devices can be provided at least at one of a proximal end, a distal end and along a length of each of the pair of jaw members.
• It is envisioned that the jaw mechanism is configured and adapted to perform an electrosurgical function. The jaw mechanism can be configured and adapted to deliver electrosurgical energy to the target surgical site.
• It is envisioned that each of the plurality of MEMS devices is electrically connected to a control box via a lead wire extending from the housing.
• The surgical instrument can further include a control box electrically connected to each of the plurality of MEMS devices via at least one wire lead.
• According to another aspect of the present invention, there is provided a robotic system for performing surgical tasks a frame, a robotic arm connected to the frame and movable relative to the frame, an actuation assembly operatively associated with the robotic arm for controlling operation and movement of the robotic arm, a loading unit including an elongate shaft operatively connected to the robotic arm, and an end effector operatively coupled to a distal end of the elongate shaft and configured to engage tissue, and at least one micro-electromechanical system (MEMS) device operatively connected to the loading unit for at least one of sensing a condition, measuring a parameter and controlling the condition and/or parameter adjacent the end effector.
• The at least one MEMS device is at least one of a pressure sensor, a strain sensor, a displacement sensor, an optical sensor, a biosensor, a temperature sensor, a torque sensor, an accelerometer, a flow sensor, an electrical sensor and a magnetic sensor for at least one of sensing, measuring and controlling an associated condition and/or parameter.
• In one embodiment the end effector includes a pair of jaw members movably coupled to the distal end of the elongate shaft. It is envisioned that a plurality of MEMS devices are provided on each of the pair of jaw members. Preferably, a plurality of MEMS devices are provided at least at one of a proximal end, a distal end and along a length of each of the pair of jaw members.
• The loading unit can be connected to the robotic arm via a bayonet-type connection.
• In another embodiment, the end effector is configured and adapted to perform an electrosurgical function. Preferably, the end effector is configured and adapted to deliver electrosurgical energy to the target surgical site.
• In yet another embodiment, the robotic system further includes a controller having a processor and a receiver for receiving electrical signals transmitted from the actuation assembly and for controlling the operation and movement of the loading unit.
• The end effector can be a fastener applier, a surgical stapler, a vessel clip applier or a vascular suturing assembly.
• As a surgical stapler, the end effector includes a staple cartridge assembly and an anvil operatively associated with the staple cartridge assembly and in juxtaposition relative to the staple cartridge assembly, and wherein at least one MEMS device is operatively connected to each of the staple cartridge assembly and the anvil. The staple cartridge assembly defines a tissue contacting surface and wherein at least one MEMS device is operatively connected to the tissue contacting surface of the staple cartridge assembly. The anvil defines a tissue contacting surface and wherein at least one MEMS device is operatively connected to the tissue contacting surface of the staple cartridge.
• The MEMS devices can be configured and adapted to measure distance between the tissue contacting surface of the staple cartridge assembly and the tissue contacting surface of the anvil. Alternatively, the MEMS devices can be are configured and adapted to measure the amount of pressure applied to tissue clamped between the tissue contacting surface of the staple cartridge assembly and the tissue contacting surface of the anvil.
• The staple cartridge assembly and the anvil are desirably transversely oriented with respect to the elongate shaft. It is envisioned that the staple cartridge assembly and the anvil are pivotably connected to the distal end of the elongate shaft.
• As a vessel clip applier, the end effector includes a body portion having a distal end and a proximal end, wherein the proximal end is operatively connectable to the robotic arm, and a jaw assembly operatively connected to the distal end of the body portion, wherein the jaw assembly includes a first and a second jaw portion. Each of the first and the second jaw portions includes at least one MEMS device operatively connected thereto.
• As a vascular suturing assembly, the end effector includes an elongate body having a distal end and a proximal end, wherein the proximal end in operatively connectable to the robotic arm, and a pair of needle receiving jaws pivotably mounted to the distal end of the elongate body portion, the pair of needle receiving jaws being configured and adapted to pass a surgical needle and associated length of suture material therebetween. Preferably, at least one MEMS component is operatively connected to each of the pair of needle receiving jaws.
• According to yet another aspect of the present invention a loading unit for use with a surgical instrument is provided and includes an elongate tubular shaft having a proximal end and a distal end, an end effector operably connected to the distal end of the tubular shaft, a connector for connecting the proximal end of the tubular shaft to a surgical instrument, and at least one micro-electromechanical system (MEMS) device operatively connected to the loading unit for at least one of sensing a condition, measuring a parameter and controlling the condition and/or parameter adjacent the end effector.
• It is envisioned that at least one MEMS device is operatively connected to the end effector. The MEMS device can be at least one of a pressure sensor, a strain sensor, a displacement sensor, an optical sensor, a biosensor, a temperature sensor, a torque sensor, an accelerometer, a flow sensor, an electrical sensor and a magnetic sensor for at least one of sensing, measuring and controlling an associated condition and/or parameter.
• It is contemplated that the surgical instrument is a surgical stapler and the end effector includes a staple cartridge assembly and an anvil operatively associated with the staple cartridge, the staple cartridge and the anvil being movably connected to one another to bring one into juxtaposition relative to the other. Each of the staple cartridge and the anvil define tissue contacting surfaces and the at least one MEMS device is operatively connected to at least one of the tissue contacting surface of the staple cartridge and the tissue contacting surface of the anvil.
• It is envisioned that a plurality of MEMS devices connected to the surgical instrument, the MEMS devices being configured and adapted to measure distance between the tissue contacting surface of the staple cartridge assembly and the tissue contacting surface of the anvil. It is further envisioned that the MEMS devices are configured and adapted to measure the amount of pressure applied to tissue clamped between the tissue contacting surface of the staple cartridge and the tissue contacting surface of the anvil. It is still further envisioned that the MEMS devices are configured and adapted to measure the thickness of the tissue clamped between the tissue contacting surface of the staple cartridge and the tissue contacting surface of the anvil.
• The end effector can be configured and adapted to perform an anastomosis. The surgical instrument can be a linear stapler that is adapted to perform an endoscopic gastrointestinal anastomosis. The surgical instrument can be an annular stapler that is adapted to perform an end-to-end anastomosis.
• It is envisioned that the end effector is a jaw mechanism including a pair of jaw members pivotably coupled to the distal end of the elongate shaft. At least one MEMS device can be provided on at least one of the pair of jaw members. The MEMS devices can be provided at least at one of a proximal end, a distal end and along a length of each of the pair of jaw members.
• It is contemplated that at least one MEMS device is a temperature sensing MEMS device. The temperature sensing MEMS device is positioned on and/or encapsulated in thermally conductive tips or elements, wherein the conductive tips are semi-rigid wires made of shape memory metal for a particular application, wherein the conductive tips are extendable out from the loading unit and into the tissue adjoining the loading unit in order to monitor temperature of the tissue adjoining the loading unit.
• According to another aspect of the present invention, a surgical instrument for use with a loading unit that is operatively couplable to the surgical instrument and has an end effector with a pair of juxtaposable jaws for performing a surgical function, the end effector having at least one micro-electromechanical system (MEMS) device operatively connected thereto for at least one of sensing a condition, measuring a parameter and controlling the condition and/or parameter adjacent the end effector. The surgical instrument includes a housing, an elongate shaft that extends from the housing and has a distal end operatively couplable to a loading unit of the above type, an approximation mechanism for approximating the pair of jaws, an actuation mechanism for activating the jaws to perform the surgical function, and at least one micro-electromechanical system (MEMS) device operatively connected to the surgical instrument for at least one of sensing a condition, measuring a parameter and controlling the condition and/or parameter adjacent the end effector and for cooperative operation with the at least one MEMS of the end effector.
• It is an object of the present disclosure to provide mechanical, electro-mechanical and energy based surgical instruments and systems having micro-electromechanical devices associated therewith to monitor, control, measure and/or regulate conditions and parameters associated with the performance and operation of the surgical instrument.
• It is a further object of the present disclosure to provide improved mechanical, electro-mechanical and energy based surgical instruments and systems which are more effective, safer and/or easier to use than similar conventional surgical instruments and systems.
• It is another object of the present disclosure to provide improved mechanical, electro-mechanical and energy based surgical instruments and systems which better control the effects they have on target tissue and on the patient.
• These and other objects will be more clearly illustrated below by the description of the drawings and the detailed description of the preferred embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the detailed description of the embodiments given below, serve to explain the principles of the disclosure.
• FIG. 1 is a perspective view of a surgical stapling instrument incorporating micro-electromechanical system devices, in accordance with the present disclosure;
• FIG. 2 is a partially exploded perspective view of an alternative surgical stapling instrument incorporating micro-electromechanical system devices in accordance with the present disclosure;
• FIG. 3 is a perspective view of yet another surgical stapling instrument incorporating micro-electromechanical system devices in accordance with the present disclosure;
• FIG. 3A is an enlarged perspective view of a distal end of the surgical stapling instrument ofFIG. 3;
• FIG. 4 is a perspective view of still another surgical stapling instrument incorporating micro-electromechanical system devices in accordance with the present disclosure;
• FIG. 5 is a perspective view of a surgical instrument for placing clips in laparoscopic or endoscopic procedures incorporating micro-electromechanical system devices in accordance with the present disclosure;
• FIG. 5A is an enlarged perspective view of the indicated region of the surgical instrument depicted inFIG. 5;
• FIG. 6 is a perspective view of an energy-based surgical instrument incorporating micro-electromechanical system devices in accordance with the present disclosure;
• FIG. 6A is an enlarged perspective view of the indicated region of the surgical instrument depicted inFIG. 6;
• FIG. 7 is a perspective view of a robotic system that employs micro-electromechanical system devices in accordance with the present disclosure;
• FIG. 8 is a block diagram illustrating the components of a disposable loading unit in accordance with the present disclosure;
• FIG. 9 is a perspective view, with portions broken away, of a robotic system coupled to a loading unit, including an end effector for applying surgical staples;
• FIG. 10 is a perspective view, with portions broken away, of a robotic system coupled to a loading unit, including an end effector for applying electrosurgical energy;
• FIG. 11 is a perspective view, with portions broken away, of a robotic system coupled to a loading unit, including an end effector for applying vessel clips; and
• FIG. 12 is a perspective view, with portions broken away, of a robotic system coupled to a loading unit, including an end effector for applying a vascular suture.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
• Preferred embodiments of the presently disclosed surgical instruments and systems will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. As used herein and as is traditional, the term “distal” will refer to that portion which is further from the user while the term “proximal” will refer to that portion which is closer to the user.
• In accordance with the present disclosure, a micro-electromechanical system (MEMS) is used to provide highly miniaturized MEMS devices and/or systems capable of performing various functions, e.g., sensing, monitoring, controlling, influencing, regulating and/or measuring various conditions and/or parameters of surgical instruments and systems, such as, for example, the distance between and/or the pressure applied by the jaws of an end effector. In the present disclosure, “controlling” is meant to include influencing and/or regulating. The MEMS devices and/or systems can also provide feedback for automatic (remote or manual) control of the operation of the surgical instrument.
• MEMS devices have the required very small size, low power requirements, and ability to be readily integrated with standard electrical systems. These characteristics make MEMS devices ideal for incorporation into and/or on surgical instruments and systems. As will be described in greater detail below, MEMS devices can be utilized in conjunction with, and incorporated into and/or on various portions and structural elements of surgical instruments and systems.
• MEMS devices and/or systems considered to be within the scope of the present disclosure, include, for example, MEMS sensors and/or sensor devices, actuator MEMS devices (motors, hydraulics, pumps, ultrasonic devices, etc.), fluid moving and mixing components, heaters, and diagnostic MEMS devices for measuring physiologic parameters and tissue properties, such as the integrity of a staple line or of a repaired or joined tissue by measuring fluid, e.g., blood flow and/or presence, and electrical signals or pressure within the stapled tissue.
• Also considered within the scope of this disclosure are: types of MEMS devices and/or systems used to determine and/or measure distance including capacitive, magnetic (Hall Effect sensors, for measuring the strength of the magnetic field between one or more magnets), light or radio frequency (RF) emitting/receiving, and optical fiber interferometric sensors; types of MEMS devices and/or systems used to determine and/or measure the amount of pressure applied to tissue including capacitive, piezoelectric, piezoresistive, resonant, light or RF emitting/receiving, and optical fiber interferometric sensors; and types of MEMS devices and/or systems used to determine and/or measure tissue thickness, and to determine or measure pressure and/or to provide pressure data to a processor which correlates the pressure data with tissue thickness using a look-up table or other data structure. By knowing the tissue thickness, the surgeon can then determine the proper size of the staples and/or tissue gap between the tissue contacting surfaces of the anvil and staple cartridge before performing the stapling procedure.
• While MEMS devices and/or systems are preferred, it is within the scope of the present disclosure and envisioned that other types of devices and/or systems can be used with or without MEMS devices and/or systems to determine and/or measure various conditions and/or parameters.
• In a preferred configuration, the surgical instrument can include one or more transducer MEMS delivery devices and/or systems capable of being powered by a battery for generating RF or other types of signals. These transducer MEMS delivery devices are aligned with transducer MEMS receiving devices capable of receiving the generated signals. Accordingly, the distance between the transducer MEMS delivery and receiving devices can be measured by a processor correlating the transmission time of the generated RF signals with distance using a data structure. By knowing the distance, the processor can then compute the thickness of the tissue clamped by the surgical instrument.
• Further, when the transducer MEMS delivery and/or receiving devices press upon the tissue clamped by the surgical instrument, pressure from the tissue is applied to the transducer MEMS delivery and/or receiving devices and/or systems. The transducer MEMS delivery and/or receiving devices and/or systems in turn determine the applied pressure and output signals.
• Alternatively, one or more transducer MEMS delivery and/or receiving components, capable of generating and receiving signals reflected off a target, can be provided on the anvil and/or the staple cartridge in order to determine the distance between the tissue contacting surfaces of the anvil and the staple cartridge for determining if the staple cartridge should be fired.
• Preferably, circuitry of the MEMS devices and/or systems amplifies the signals, before being transmitted to standard electrical components or to the processor, for analysis using conventional algorithms implemented as a set of programmable instructions. The processor analyzes the reading to determine if the reading is within the desired limits for the surgical instrument and/or the current application. The processor can use at least one or more comparators to compare the value of the determined reading with stored, predetermined values.
• If the determined reading is within the desired limits for the surgical instrument, then the surgical instrument can be fired as usual. However, if the reading is outside of the desired limits, the surgical instrument and/or the operator can: (1) prevent the firing of the surgical instrument until the reading is within the desired limits; (2) adjust the components of the surgical instrument in order to alter the reading as needed; (3) alert the operator; and/or (4) wait a few moments and then take the reading again.
• Further, the measured readings received from the MEMS devices and/or systems can also be used to control the firing of the surgical instrument. For example, if the tissue thickness is large, the firing of the surgical instrument can be automatically or manually adjusted in order for the surgical instrument to be fired with sufficient power to affect all of the tissue. The reading of tissue thickness can also be used by a surgeon to determine whether the power applied by the surgical instrument is large enough to penetrate and affect all of the tissue.
• The MEMS devices and/or systems are preferably positioned at opposing or juxtaposed locations when used to measure and/or determine distances. The MEMS devices are also preferably positioned on tissue contacting surfaces of the surgical instrument in order to measure and/or determine a distance between the tissue contacting surfaces of the surgical instrument as one or more structural components of the surgical instrument is/are moved relative to one another. It is further envisioned that MEMS devices and/or systems are capable of measuring and/or determining a thickness of tissue clamped between the tissue contacting surfaces of the surgical instrument.
• Other types of MEMS devices and/or systems that can be used within the scope of the present disclosure include strain, optical, flow, electrochemical and bio-sensors. Optical sensors for fluorescence and absorption for determining, for example, the presence of blood glucose, and hence, the presence of blood, require fiber optic connections to photodetectors and/or photomultiplier tubes that may or may not be miniaturized. Biosensors can be used to measure tissue characteristics before and/or after the stapling procedure. That is, bio-sensors can be used to ensure that the tissue is in condition or acceptable for stapling, or as a check after the staples have been fired to ensure that the tissue is healthy (e.g., has good blood flow, is healing properly, etc).
• Turning now toFIGS. 1-4, specific embodiments of several representative surgical staplers including MEMS devices “M”, in accordance with the present disclosure, are shown. As seen inFIG. 1, a first embodiment of a surgical stapler, here, a transverse anastomotic stapler, in accordance with the present disclosure, is shown generally as100.Surgical stapler100 includes ahousing112 including astationary handle114, a distally extendingbody portion116 operatively connected tohousing112, and atransverse body portion115 operatively connected to distally extendingbody portion116.Transverse body portion115 is configured and adapted to operatively receive asupport frame118 in a distal end thereof.
• Surgical stapler100 further includes ananvil120 fastened to afirst leg124 or distal portion ofsupport frame118 and extending transversely acrosstransverse body portion115.Surgical stapler100 further includes astaple cartridge assembly122 operatively received withintransverse body portion115. Each ofanvil120 andstaple cartridge assembly122 include juxtaposedtissue contacting surfaces120a,122a, respectively. Atrigger actuator134 is operatively connected to handle114 and is configured and adapted to distally advancestaple cartridge assembly122 towardanvil120 in order to firesurgical stapler100.
• In accordance with the present disclosure,surgical stapler100 includes a plurality of MEMS devices “M” provided at specific locations thereon. In particular, by way of example only and in no way is it to be considered as limiting, as seen inFIG. 1, MEMS devices “M” can preferably be provided along the length oftissue contacting surface120aofanvil120, along the length oftissue contacting surface122aofstaple cartridge assembly122 and/or onstaple cartridge assembly122 andtransverse body portion115.
• As described above, MEMS devices “M” enable, for example, the measurement of various parameters ofsurgical stapler100, such as, for example, the distance betweentissue contacting surfaces120aand122aofsurgical stapler100, as well as the amount of pressure applied to tissue clamped betweentissue contacting surfaces120a,122a. It is further envisioned that MEMS devices “M” are capable of measuring and/or determining a thickness of the tissue clamped betweentissue contacting surfaces120a,122a.
• It is envisioned that MEMS devices “M” may transmit feedback signals of the measured and/or sensed parameters to a central processing unit “CPU” (e.g.,control box562 ofFIG. 6) or actuation assembly612 (seeFIG. 7), via wire leads560 (seeFIG. 6) or transmission wires “W” (seeFIG. 7), for further processing. Alternatively, it is contemplated that MEMS devices “M” can transmit feedback signals of the measured and/or sensed parameters to the CPU via wireless transmissions.
• Reference is made to commonly assigned U.S. Pat. No. 5,964,394 to Robertson, the entire content of which is incorporated herein by reference, for a more detailed explanation of the operation ofsurgical stapler100.
• Turning now toFIG. 2, an alternative embodiment of a surgical stapler, here, an open gastrointestinal anastomotic stapler, in accordance with the present disclosure, is shown generally as200.Surgical stapler200 includes a cartridge receiving half-section212, an anvil half-section214 operatively couplable to cartridge receiving half-section212, astaple cartridge assembly216 configured and adapted to be removably mounted within a distal end of cartridge receiving half-section212, and ananvil218 operatively mounted to a distal end of anvil half-section214.Staple cartridge assembly216 includes atissue contacting surface216aandanvil218 includes atissue contacting surface218ajuxtaposed totissue contacting surface216aofstaple cartridge assembly216.
• In accordance with the present disclosure,surgical stapler200 includes a plurality of MEMS devices “M” provided at specific locations thereon. In particular, by way of example only and in no way is it to be considered as limiting, as seen inFIG. 2, MEMS devices “M” can preferably be provided along the length of or as shown, at specific locations ontissue contacting surface218aofanvil218, along the length oftissue contacting surface216aofstaple cartridge assembly216, on the distal end portions of cartridge receiving half-section212 and anvil half-section214.
• As described above, MEMS devices “M” enable the measurement of various parameters ofsurgical stapler200, such as, for example, the distance betweentissue contacting surfaces216aand218aofsurgical stapler200, as well as the amount of pressure applied to tissue clamped betweentissue contacting surfaces216a,218aofsurgical stapler200.
• Reference is made to commonly assigned U.S. Pat. No. 6,045,560 to McKean et al., U.S. Pat. No. 6,032,849 to Mastri et al., and U.S. Pat. No. 5,964,394 to Robertson, the entire contents of each of which are incorporated herein by reference, for a more detailed explanation of the operation ofsurgical stapler200.
• Turning now toFIGS. 3 and 3A, yet another embodiment of a surgical stapler, here, an endoscopic gastrointestinal anastomotic stapler, in accordance with the present disclosure, is shown generally as300. Briefly,surgical stapler300 includes ahandle assembly312 and anelongated body314. A disposable loading unit orDLU316 is releasably secured to a distal end ofelongated body314.Disposable loading unit316 includes anend effector317 having astaple cartridge assembly318 housing a plurality of surgical staples (not shown) and ananvil320 movably secured in relation tostaple cartridge assembly318.Staple cartridge assembly318 includes atissue contacting surface318aandanvil320 includes atissue contacting surface320ajuxtaposed totissue contacting surface318aofstaple cartridge assembly318.
• Handle assembly312 includes astationary handle member322, amovable handle member324 and abarrel portion326. Arotatable member328 is preferably mounted on the forward end ofbarrel portion326 to facilitate rotation ofelongated body314 with respect to handleassembly312. Anarticulation lever330 is also preferably mounted on the forward end ofbarrel portion326 adjacentrotatable knob328 to facilitate articulation ofend effector317.
• In accordance with the present disclosure,surgical stapler300 includes a plurality of MEMS devices “M” provided at specific locations thereon. In particular, by way of example only and in no way is it to be considered as limiting, as seen inFIGS. 3 and 3A, MEMS devices “M” can be provided preferably along the length oftissue contacting surface320aofanvil320, along the length oftissue contacting surface318aofstaple cartridge assembly318, ondisposable loading unit316, onelongated body314 and/or onhandle assembly312.
• As described above, MEMS devices “M” enable the measurement of various parameters ofsurgical stapler300, such as, for example, the distance betweentissue contacting surfaces318aand320aofsurgical stapler300, as well as the amount of pressure applied to tissue clamped betweentissue contacting surfaces318a,320aofsurgical stapler300.
• In another preferred configuration, as shown inFIGS. 3 and 3A, MEMS devices “M” are positioned in proximity to a pivot point ofanvil320 andstaple cartridge assembly318 ofsurgical stapler300. Other MEMS devices “M” are positioned remotely from the pivot point. It is envisioned that the MEMS devices “M” positioned onanvil320 andstaple cartridge assembly318 can be of the type capable of emitting light from laser diodes or from a fiber optic waveguide. In particular, a MEMS device in the form of a MEMS light producing sensor/device (e.g., bicell or photodiode) is positioned opposite an aforementioned MEMS device for detecting changes in the amount of light being received as a result of the changing angle of rotation betweenanvil320 andstaple cartridge318.
• Accordingly, in use, if the amount of light being received is high, a MEMS light producing device and its corresponding MEMS light detection device are close to each other. Accordingly, the distance betweenanvil320 andstaple cartridge assembly318 is small, and, if there is any tissue clamped betweenanvil320 andstaple cartridge assembly318, the thickness of the tissue is also small. If the amount of light being received is low, the MEMS light producing device and its corresponding MEMS light detection device are further from each other. Accordingly, the distance betweenanvil320 andstaple cartridge assembly318 is large, and, if there is any tissue clamped betweenanvil320 andstaple cartridge assembly318, the thickness of the tissue is also large.
• Distance and tissue thickness can also be determined by timing the duration until the MEMS light detection device senses light once the MEMS light producing device is turned on. If the MEMS light detection device senses light, for example, at time t₀after the MEMS light producing device is turned on, thenanvil320 andstaple cartridge assembly318 are in close proximity or touching (small tissue thickness). If the MEMS light detection device senses light, for example, at time t₀+t₁after the MEMS light producing device is turned on, thenanvil320 andstaple cartridge assembly318 are at a predetermined distance from each other. Also, if there is any tissue clamped betweenanvil320 andstaple cartridge assembly318, then the tissue thickness is a predetermined tissue thickness. The predetermined distance and tissue thickness can be determined by a processor accessing one or more look-up tables or other data structures and correlating the measured time to distance and, then correlating the distance to tissue thickness.
• Reference is made to commonly assigned U.S. Pat. Nos. 5,865,361, 6,330,965 and 6,241,139 to Milliman et al., the entire contents of which are incorporated herein by reference, for a more detailed explanation of the operation ofsurgical stapler300.
• Turning now toFIG. 4, an alternative embodiment of a surgical stapler, in accordance with the present disclosure, is shown generally as400. Briefly,surgical stapler400 includes ahandle assembly412 having at least one pivotableactuating handle member414 and an advancingmember416 configured and adapted to open and closesurgical stapler400.Surgical stapler400 further includes atubular body portion420 extending fromhandle assembly412, an annularstaple cartridge assembly422 operatively connected to a distal end oftubular body portion420, and anannular anvil426 positioned oppositestaple cartridge assembly422 and connected tosurgical stapler400 by ashaft428.Staple cartridge assembly422 includes atissue contacting surface422aandanvil426 includes atissue contacting surface426ain juxtaposition relative totissue contacting surface422aofstaple cartridge assembly422.
• In accordance with the present disclosure,surgical stapler400 includes a plurality of MEMS devices “M” provided at specific locations thereon. In particular, by way of example only and in no way is it to be considered as limiting, as seen inFIG. 4, at least one MEMS device “M” can be provided preferably ontissue contacting surface426aofanvil426,tissue contacting surface422aofstaple cartridge assembly422, onshaft428 and/or onhandle assembly412.
• As described above, MEMS devices “M” enable the measurement of various parameters ofsurgical stapler400, such as, for example, the distance betweentissue contacting surfaces422aand426aofsurgical stapler400, as well as the amount of pressure applied to tissue clamped betweentissue contacting surfaces422a,426aofsurgical stapler400.
• Reference is made to commonly assigned U.S. Pat. No. 5,915,616 to Viola et al., the entire content of which is incorporated herein by reference, for a more detailed explanation of the operation ofsurgical stapler400.
• While MEMS devices for determining distance and/or pressure are shown located at certain discrete positions on the structural elements of the surgical staplers shown inFIGS. 1-4, it is within the scope of the present disclosure that MEMS devices for determining distance and/or pressure can be positioned anywhere on the structural elements of the surgical staplers.
• InFIGS. 1-4, MEMS devices “M” are merely located at representative positions and are not intended to be indicative of the only positions where MEMS devices “M” can be provided or the numbers of MEMS devices “M” that can be provided. It is envisioned that a staple cartridge holding component of the surgical stapler, including a staple cartridge, can be automatically or manually moved away from an anvil if the pressure applied to the clamped tissue is above a predetermined threshold. The surgical stapler can also be automatically or manually prevented from being fired in response to the feedback provided by MEMS devices “M”. The feedback provided by MEMS devices “M” could be in the form of feedback signals (e.g., audio, visual and/or audiovisual), and/or in the form of mechanical feedback (e.g., a tactile indication).
• The surgical staplers disclosed herein can be fitted with different-sized surgical staples (i.e., staples having varying length legs) and can be adapted to automatically select the proper sized staples for performing a or the particular surgical procedure according to information obtained by the MEMS devices “M”.
• Turning now toFIGS. 5 and 5A, in which like reference numerals identify similar or identical elements, a surgical instrument for placing clips in laparoscopic or endoscopic procedures employing the novel features of the present disclosure is generally designated with thereference numeral450.
• As seen inFIG. 5,surgical instrument450 includes ahandle portion452 having pivoting ormovable handle454 andstationary handle456. Manipulation ofhandles454,456 actuates a tool assembly, such as ajaw assembly458, throughelongated body460 which extends distally fromhandle portion452.Elongated body460 is preferably rotatable with respect to handleportion452 by turningknob459.Jaw assembly458 includes first and secondjuxtaposed jaw portions462a,462b, respectively, which are simultaneously movable between a substantially approximated position, in whichjaw portions462aand462bare in relatively close relation to one another, and a spaced position, in whichjaw portions462aand462bare separated at least a sufficient distance to receive an unformed surgical clip464 (seeFIG. 5A) therebetween.
• It is envisioned that a plurality ofsurgical clips464 are stored in aloading unit466 which is releasably mounted toelongated body460. In a preferred embodiment,loading unit466 is disposable (i.e., in the form of a disposable loading unit or “DLU”) subsequent to depletion of the supply ofsurgical clips464 stored therein. The remainder ofsurgical instrument450 may be disassembled, resterilized and reused in combination with another loading unit containing a supply ofsurgical clips464.
• In use, approximation ofmovable handle454 towardstationary handle456 results in the advancement of a distal-mostsurgical clip464 to a position betweenjaw portions462aand462b. Further approximation ofhandles454,456 toward one another results in the approximation ofjaw portions462aand462btoward one another to form the surgical clip disposed therebetween.
• In accordance with the present disclosure,surgical instrument450 includes a plurality of MEMS devices “M” provided at specific locations thereon. In particular, by way of example only and in no way is it to be considered limiting, as seen inFIGS. 5 and 5A, at least one MEMS device “M” can be provided preferably on the tissue contacting surface of at least one, preferably each,jaw portion462a,462bofjaw assembly458, onloading unit466 and/orelongated body460, and/or onhandle portion452.
• As described above, MEMS devices “M” enable the measurement of various parameters ofsurgical instrument450, such as, for example, the distance between the tissue contacting surfaces ofjaw portions462a,462b, as well as the amount of pressure applied to tissue clamped betweenjaw portions462a,462b. It is further envisioned that MEMS devices “M” are capable of measuring and/or determining a thickness of the tissue clamped between tissue contacting surfaces ofjaw portions462a,462b.
• Reference is made to commonly assigned U.S. Pat. No. 6,059,799 to Aranyi et al., the entire content of which is incorporated herein by reference, for a more detailed explanation of the operation ofsurgical instrument450.
• Turning now toFIGS. 6 and 6A, in which like reference numerals identify similar or identical elements, a surgical instrument employing the novel features of the present disclosure is generally designated with thereference numeral500.
• As seen inFIG. 6,surgical instrument500 includes ahousing512 having a fixedhandle portion514, amovable handle portion516, anelongated shaft518 extending distally fromhousing512, and ajaw mechanism522 operatively coupled to a distal end ofshaft518. As seen in detail inFIG. 6A,jaw mechanism522 includes a pair ofjaw members580,582 which are pivotable aboutpin519 in order to provide the opening and closing ofjaw mechanism522.Surgical instrument500 is configured and adapted such that, in operation, manipulation ofmovable handle portion516, distally and proximally, relative to fixedhandle portion514, causesjaw members580,582 ofjaw mechanism522 to open and close.Jaw members580,582 are shown as being configured and adapted to perform an electrosurgical function, such as, for example, coagulation, cauterization and the like.
• Jaw mechanism522 can be configured to grasp, staple, cut, retract, coagulate and/or cauterize. The above examples are merely intended to be illustrative of a few of the many functions whichjaw mechanism522 can be configured to accomplish and in no way is intended to be an exhaustive listing of all of the possible jaw or like or pivotable structures.
• As further shown inFIG. 6A,jaw mechanism522 is provided with a plurality of micro-electrosurgical system (MEMS) devices “M” placed at specific desired locations on, in or along the surfaces ofjaw members580,582. For example, MEMS devices “M” can be placed near a proximal end and/or near a distal end ofjaw members580,582, as well as along the length ofjaw members580,582.
• In one preferred embodiment of the present disclosure, MEMS devices “M” offer a solution for controlling the amount of energy delivered, by radio frequency (e.g., monopolar or bipolar), ultrasonic, laser, argon beam or other suitable energy systems, to tissue during treatment with energy based electrosurgical instruments, for example, electrocautery surgical instruments. In electrocautery surgical instruments the degree of tissue cutting, coagulation and damage are influenced by the power setting, the force applied by the jaw mechanism of the electrocautery surgical instrument to the tissue, the duration of contact between the jaw mechanism of the electrocautery surgical instrument and the tissue, as well as other factors.
• Accordingly, it is contemplated that energy sensing MEMS devices “M”, capable of measuring and/or sensing energy, be used to monitor, control, measure and/or regulate the amount of energy delivered bysurgical instrument500 to the tissue. Energy sensing MEMS devices “M” can provide feedback to electronics within the electrocautery instrument, for example, to create a more consistent desired tissue effect. In particular, it is envisioned that selected MEMS devices “M” are configured and adapted to be force and/or pressure sensing MEMS devices so that a pressure or a gripping force applied to the tissue byjaw members580,582 can be sensed and regulated.
• It is further envisioned that selected MEMS devices “M” can be configured and adapted to measure temperature on or near an active blade (not shown) of surgical instrument500 (i.e., an electrocautery instrument, electrosurgical pencil, etc.). These temperature sensing MEMS devices “M” can be used to monitor and control the temperature of the active blade of the electrocautery instrument, such that the active blade is able to reach and maintain a specific temperature, for example, by having intermittent bursts of energy supplied to the active blade or by controlling the power or energy delivered to the active blade whenever the temperature of the active blade drops below a certain threshold level.
• In one embodiment, it is envisioned that these temperature sensing MEMS devices “M” can be thermocouples positioned directly on a probe or an instrument and electrically and thermally insulated from the same for the sensing and/or measuring the temperature of tissue located adjacent thereto. It is further contemplated that, due to their relatively smaller size and sensitivities, temperature sensing MEMS devices “M” can be positioned on and/or encapsulated in thermally conductive tips or elements that could be semi-rigid wires or wires made of shape memory metals for a particular application that could be extended out from the probe and into the tissue adjoining a treatment probe in order to monitor the temperature of the tissue adjoining the treatment probe.
• It is further contemplated that selected MEMS devices “M” are configured and adapted to be current sensing MEMS devices for regulating and monitoring electrical current delivered to the active blade and through the tissue. It is envisioned that the flow or amount of current could be regulated to stop after delivery of a specific amount of energy or after reaching a specific current value.
• In addition, it is contemplated that selected MEMS devices “M” are configured and adapted to control the energy treatment by detecting the distance between moveable elements, such as, for example, jaws having electrodes, in order to maintain the jaws at an optimal distance for one or more aspects of a given treatment application. For example, distance sensing MEMS devices “M” can be employed to use light beams emitted from laser diodes and/or guided through fiber optics in conjunction with a detecting device, such as, for example, a bicell or a photo diode positioned directly on the tip of the probe or at a remote location suitable for measuring the relative distance between portions of the jaws.
• In an alternative embodiment of the present disclosure, it is envisioned that MEMS devices “M” are configured and adapted to be accelerometer MEMS devices “M”, which accelerometers detect frequencies by displacement of a cantilevered or tuned element associated with MEMS devices “M”. Accordingly, when the surgical instrument is an energy based surgical instrument, for example, of the cutting or coagulating type (e.g., electrosurgical instrument) which includes ajaw mechanism522 as described above, MEMS devices “M” employing suitable sensors can be employed for measuring the acceleration and displacement ofjaw members580,582 in relation to each other. Accordingly, accelerometer MEMS devices “M” can be positioned on individual components, such as, for example, eachjaw580,582, to measure their relative acceleration, on the overallsurgical instrument500 or on a fixed blade which performs the coagulating and cutting functions, such as, for example, an electrosurgical pencil to measure the acceleration of the instruments a whole, or a combination thereof.
• When accelerometer MEMS devices “M” are employed and suitably integrated as two or three orthogonal assemblies, they effectively constitute a two-dimensional or three-dimensional acceleration measuring device or gyroscope type device when provided with a known point of origination and appropriately configured computer system. In this embodiment, MEMS devices “M” can be advantageously employed as a passive system for tracking the distance between the jaws, position of the instrument relative to the target tissue portion and duration of treatment.
• A further application for MEMS devices “M” in surgical instruments such as electrosurgical cutting or coagulating devices includes torque sensing. It is contemplated that selected torque sensing MEMS devices “M” can be properly positioned on eachjaw member580,582, onjaw mechanism522 or on a combination of both. Torque sensing MEMS devices “M” can be configured and adapted to employ strain sensors or optical measuring systems, for example. It is envisioned that, torque sensing MEMS devices “M” can be configured to detect the deflection at different points along the element or handle of the instrument relative to one another. Accordingly, the deflection of portions of the surgical instrument, at predetermined points and angles of application of torque sensing MEMS devices “M”, could be equated to an applied force or torque. Strain sensors or fiber optic or integrated waveguide structure in conjunction with a detection system could be used to detect, measure and control the degree of force applied to or exerted by components by monitoring the relative changes in distance or deflection of portions of the instrument.
• Preferably, as seen inFIG. 6, MEMS devices “M” are electrically coupled to acontrol box562 via wire leads560 extending fromhousing512. It is envisioned that wire leads560 travel throughhousing512 andshaft518 to MEMS devices “M”. In a preferred embodiment, MEMS devices “M” andcontrol562 box are electrically coupled to a feedback circuit (not shown). The feedback circuit would continually monitor and transmit signals and parameters between MEMS devices “M” andcontrol box562.
• MEMS devices “M”, such as those described above, may also be employed individually or in combination with traditional sensor systems, such as, for example, loss detection circuitry between elements of the instrument, and can be suitably configured to provide feedback to an electronic control system (e.g., computer, microprocessor, programmable logic controller or combination thereof) for tracking each reported feedback parameter relative to predefined criteria for the automatic adjustment and control of the energy delivered by the instrument in order to, e.g., measure, determine, verify and/or control the effectiveness of the treatment and proper performance of the surgical instrument. The control system would preferably also be configured with logic to weight the inputs of each parameter sensed by a MEMS device “M” and accommodate the selective manual operation of any parameter. Thus, parameters of MEMS devices “M” may be integrated into a single computerized display system or separately monitored, for example, by the display system or by simple audible, visual or tactile warning systems. The control system could be integrated at least partially into the instrument or a separate system connected to the instrument.
• By way of example only, in accordance with the present disclosure, it is envisioned that the MEMS devices “M” can include pressure measuring devices (i.e., capacitive, piezoresistive, piezoelectric, resonant and/or optical fiber interferometric, etc.), strain measuring devices (i.e., piezoresistive, piezoelectric and/or frequency modulation, etc.), displacement measuring devices (i.e., capacitive, magnetic and/or optical fiber interferometric), optical (i.e., fluorescence, absorption and/or optical fiber interferometric), biosensors (for measuring, i.e., glucose, neural probes, tactile, pH, blood gases) and/or immunosensors, temperature sensors, torque sensors, accelerometers, flow sensors and electrochemical and/or electromagnetic sensors, and combinations of the above.
• In accordance with the principles of the present disclosure, as seen inFIGS. 7-12, it is envisioned that the above described surgical instruments, together with their respective incorporated MEMS devices “M” can be employed with or interface directly with a roboticsurgical system600. An exemplary robotic surgical system is disclosed in commonly assigned U.S. Pat. No. 6,231,565 to Tovey et al., the entire contents of which is incorporated herein by reference.
• Generally, robotic surgical systems include surgical instrument or systems, either powered locally or remotely, having electronic control systems localized in a console or distributed within or throughout the surgical instrument or system. The surgical instrument systems can be powered and controlled separately from the robotic system or, in the alternative, the power and control systems can be integrated or interfaced with the robotic surgical system.
• In particular, as seen inFIG. 7, roboticsurgical system600 includes anactuation assembly612, amonitor614, arobot616 and aloading unit618 releasably attached torobot616 and having at least onesurgical instrument620 for performing at least one surgical task operatively connected thereto.Robot616 includes atrunk622 extending from abase624, ashoulder626 connectingtrunk622 to anupper arm628, anelbow630 connectingupper arm628 to alower arm632, and awrist634 attached tolower arm632 from which extends a mountingflange636. Preferably, mountingflange636 is capable of moving in six degrees of freedom.
• As used herein, “loading unit” is understood to include disposable loading units (e.g., DLU's) and single use loading units (e.g., SULU's). SULU's include removable cartridge units, e.g., for open gastrointestinal anastomosis and transverse anastomosis staplers and include removable units, e.g., those having ashaft316, acartridge assembly318 and an anvil317 (see, e.g.,FIG. 3 hereof). These latter removable units, which can be modified, are sometimes referred to as DLU's (e.g., see618 inFIGS. 7 and 718 inFIG. 9).
• Disposable loading unit618 further includes ahead portion640 for housing an electro-mechanical assembly619 (seeFIG. 8) therein for operatingsurgical instrument620 and anattachment platform642 for releasably attachingdisposable loading unit618 torobot616 via mountingflange636. Mountingflange636 preferably includes twoslots635 which inter-engage withprotrusions638 ofplatform642 to connect to mountingflange636 withdisposable loading unit618. It is further contemplated that an electrical connection633 (seeFIG. 8) be provided betweenslots635 andprotrusions638 in order to provide power to electro-mechanical assembly619.
• Disposable loading unit618, which could be a surgical instrument as contemplated herein, can be removed from mountingflange636 and be replaced with another such disposable loading unit, or surgical instrument, for performing a different surgical procedure. By way of example only and in no way to be considered as limiting, potential surgical instruments or systems which can interface withrobotic system600 include various hand instruments, e.g., graspers, retractors, specimen retrieval instruments, endoscopic and laparoscopic instruments, electrosurgical instruments, stapling or fastener applying instruments, coring instruments, cutting instruments, hole-punching instruments, suturing instruments and/or any combination thereof. It is envisioned that each of these instruments be provided with at least one, preferably a plurality of MEMS devices “M” as described above, for providing feedback to the user. It is further contemplated that MEMS devices “M” can provide feedback directly torobotic system600 in order forrobotic system600 to respond, e.g., adapt in response to the feedback and/or provide notification to the user ofrobotic system600. It is further envisioned that a plurality of sensors can be incorporated into, e.g., provided on an energy based surgical instrument, which energy based surgical instrument can also be interfaced withrobotic system600. Accordingly, the energy provided to the energy based surgical instrument can be delivered and controlled directly byrobotic system600 for improved user interfaces and better system integration.
• In operation, the user (e.g., surgeon, nurse, technician, etc.) controlsactuation assembly612 to control the movement and operation ofrobot616 anddisposable loading unit618. Depending on the amount of rotation ofknobs644 onactuation assembly612,actuation assembly612 transmits electrical signals torobot616 to electro-mechanically operate the moveable parts ofrobot616, such as to rotaterobot616 aboutvertical trunk622 or to advance mountingflange636.Actuation assembly612 may include a processor therein for storing operational commands and for transmitting digital signals to electro-mechanical assembly619.Actuation assembly612 can also transmit electrical signals to mountingflange636 in the form of electrical signals, for example, for positioning andoperating loading unit618.
• Actuation assembly612 preferably is adapted to transmit electrical signals to an electro-mechanical assembly619 housed withinhead portion640 ofloading unit618 for actuating electro-mechanical assembly619 which in turn actuatessurgical instrument620. Electro-mechanical assembly619 includes mechanisms for moving and operatingsurgical tool instrument620, such as, for example, servo motors for harmonically oscillating a scalpel of a cutting instrument, or rods for pivotally moving a suturing needle positioned on an axis of a longitudinal casing of a suturing instrument.
• As seen inFIG. 8,disposable loading unit618 may further include integrated circuitry for receiving digital signals fromactuation assembly612, such as, for example, areceiver621 and aprocessor623.Receiver621 andprocessor623 are included within control means625 electrically connected to electro-mechanical assembly619.
• By way of example only, as shown inFIG. 9, adisposable loading unit718, hereinafter sometimes referred to asloading unit718, including an end effector of a surgical stapler, similar to the end effector ofsurgical stapler100 described above, is operatively connected to robot616 (seeFIG. 7) such that an array of surgical fasteners (e.g., staples) can be applied to body tissue. In particular,loading unit718 includes a distally extendingbody portion716, atransverse body portion715, andsupport frame719 operatively received in a distal end oftransverse body portion715.Loading unit718 further includes ananvil720 and astaple cartridge assembly722 operatively received withintransverse body portion715. Each ofanvil720 andstaple cartridge assembly722 include juxtaposedtissue contacting surfaces720a,722a, respectively.
• It is envisioned thatloading unit718 includes an actuator incorporated within ahead portion792 to perform fast closure and incremental advancement ofstaple cartridge assembly722 with respect toanvil720. As described above, relative tosurgical stapler100, MEMS devices “M” can be provided onanvil720 andstaple cartridge assembly722 to provide feedback information torobot616.
• Examples of direct information that can be fed back torobot616 from MEMS devices “M” ofloading unit718 or other MEMS devices include, for example, whether staples have been fired or, in the case of an electrosurgical instrument, the amount of energy delivered. MEMS device “M” can also be used to make indirect measurements of performance, such as, for example, detecting the status of staple firing by measuring the position of the assembly member responsible for pushing the staples out of the cartridge. Alternatively, MEMS devices “M” can measure an associated member, such as a displacement of a drive rod or a rotation of a screw rod to determine whether the staples have been fired or not. In either instance,robotic system600 can accept the information fromloading unit718 and respond accordingly, for example, by either altering performance, making adjustments, notifying the user, modifying or stopping operation or any combination thereof.
• Reference is made to commonly assigned U.S. Pat. No. 5,964,394 to Robertson, the entire content of which is incorporated herein by reference, for a more detailed explanation of the operation and internal working of the components of the end effector of the surgical stapler operatively coupled to the distal end ofloading unit718.
• As seen inFIG. 10, a loading unit including a distal end portion capable of performing an electrosurgical function, similar tosurgical instrument500 above, is shown generally as800. In particular,loading unit800 includes ahead portion802 configured and adapted to be removably coupled to mountingflange636 ofrobot616, anelongate shaft818 extending distally fromhead portion802, and ajaw mechanism822 operatively coupled to a distal end ofshaft818.Jaw mechanism822 includes a pair ofjaw members880,882 which are pivotable aboutpin819 in order to provide the opening and closing ofjaw mechanism822.Jaw members880,882 are preferably configured and adapted to perform an electrosurgical function, such as, for example, coagulation, cauterization and the like.
• Loading unit800 is preferably further provided with MEMS devices “M” placed near a proximal end, a distal end, approximately mid-way and/or all along the length of eachjaw member880,882 in order to provide feed back information torobot616. Accordingly, in the case ofloading unit800, MEMS devices “M” can feed back, torobot616 andactuation assembly612, information regarding, for example, the amount of energy delivered, the clamping force being applied byjaw members880,882, the temperature at the target surgical site and the like.
• Turning now toFIG. 11, a loading unit including a vessel clip applying end effector, for applying surgical clips to body tissue, for example, for occluding vessels, is shown generally as900.Loading unit900 includes ahead portion902, abody portion904 extending distally fromhead portion902, and a plurality of surgical clips (not shown) disposed withinbody portion904. Ajaw assembly906 is mounted adjacent adistal end portion908 ofbody portion904.Jaw assembly906 includes a first and asecond jaw portion910a,910b, respectively, which are movable between a spaced-apart and approximated position relative to one another.
• A clip pusher (not shown) is provided withinbody portion904 to individually distally advance a distal-most surgical clip tojaw assembly906 while first andsecond jaw portions910a,910bare in the spaced-apart position. Anactuator912, disposed withinbody portion904, is longitudinally movable in response to actuation of electro-mechanical assembly619 provided withinhead portion902. Ajaw closure member914 is positioned adjacent first andsecond jaw portions910a,910bto movejaw portions910a,910bto the approximated position.Actuator912 andjaw closure member914 define an interlock therebetween to produce simultaneous movement ofactuator912 andjaw closure member914 whenactuator912 is positioned adjacent the distal end portion ofbody portion904.
• It is envisioned thatloading unit900 preferably includes at least one MEMS device “M” operatively connected to each of the first andsecond jaw portions910a,910bto provide feedback information torobot616.
• Reference is made to commonly assigned U.S. Pat. No. 6,059,799 to Aranyi et al., the entire content of which is incorporated herein by reference, for a more detailed explanation of the operation and internal working of the components of the vessel clip applying end effector ofloading unit900.
• Turning now toFIG. 12, a loading unit including a vascular suture applying end effector, for suturing vascular tissue sections together, is shown generally as950.Loading unit950 includes ahead portion952 and abody portion954 extended distally therefrom. A pair ofneedle receiving jaws956,958 are pivotally mounted at a distal end ofbody portion954 and are configured to repeatedly pass asurgical needle960 and associated length of suture material therebetween.Loading unit950 further includes needle holding structure (not shown) mounted withinjaws956 for reciprocal movement into and out ofneedle holding recesses962 formed injaws956,958. During an anastomosis procedure,loading unit950 will advantageously respond to movement commands transmitted from the actuation assembly to apply fasteners to tissue.
• It is envisioned thatloading unit950 preferably includes at least one MEMS device “M” operatively connected to each of the pair ofneedle receiving jaws956,958 to provide feedback information torobot616. It is contemplated that MEMS device “M” can, for example, provide information relating to the position ofjaws956,958, whether and in whichjaw needle960 is disposed, and the force being exerted onneedle960.
• Reference is made to commonly assigned U.S. Pat. No. 5,478,344 to Stone et al., the entire content of which is incorporated herein by reference, for a more detailed explanation of the operation and internal working of the components of the vascular suture applying end effector ofloading unit950.
• An advantage of using MEMS devices in conjunction with robotic systems, similar to those described above, is that conditions and forces sensed by the MEMS devices provided on the end effectors of the loading units can be fed back system to the robotic systems or transmitted to a user interface.
• Current robotic systems allow little to no tactile information to reach or be transmitted from the patient back to the hands of the user (i.e., the surgeon). Accordingly, by using MEMS devices, in accordance with the present disclosure, in combination with a feedback and control system, conditions and forces experienced by the distal end of the end effectors due to the interaction of the end effector with the tissue of the patient can be “felt” and/or monitored by the surgeon, thus greatly improving the surgeon's information and, in turn, ability to perform surgical procedures.
• In accordance with the present disclosure, it is contemplated to have feedback of information, data, signals, conditions and forces, initiated by pressure and/or other parameters indicative of the surgical task being performed by the end effector of the disposable loading unit and measured and/or sensed by MEMS devices provided on the loading unit, and to transmit this feedback to a control system. This feedback control system allows the robotic system to be programmed, before the surgical task is performed, with guidance, pressure, and other parameters which can be continuously monitored to control the operation and movement of the loading unit and of the associated end effector.
• Although the illustrative embodiments of the present disclosure have been described herein, it is understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be affected therein by one skilled in the art without departing from the scope or spirit of the disclosure. All such changes and modifications are intended to be included within the scope of the disclosure.

Claims (17)

1. (canceled)

2. A method of performing a surgical procedure, comprising:

positioning tissue between a pair of jaw members of a surgical instrument, at least one jaw member of the pair of jaw members having a biosensor;

measuring a biological characteristic of the tissue using the biosensor; and

determining, using the measured biological characteristic of the tissue, whether the tissue is in condition for stapling.

3. The method according toclaim 2, wherein the biological characteristic of the tissue is indicative of at least one of blood flow through the tissue, blood flow presence in the tissue, or blood pressure in the tissue.

4. The method according toclaim 3, wherein the tissue is determined to be in condition for stapling when the measured biological characteristic through the tissue meets a threshold.

5. The method according toclaim 2, further comprising:

firing staples from the surgical instrument into a portion of the tissue after determining that the tissue is in condition for stapling;

measuring the biological characteristic of the stapled portion of the tissue after the staples are fired; and

determining, using the biological characteristic of the tissue measured after the staples are fired, whether the stapled portion of the tissue is healthy or viable.

6. The method according toclaim 5, wherein the biological characteristic of the tissue is indicative of at least one of blood flow through the tissue, blood flow presence in the tissue, or blood pressure in the tissue.

7. The method according toclaim 5, wherein the stapled portion of the tissue is determined to be healthy when a characteristic measured by the biosensor is above a threshold amount.

8. The method according toclaim 2, further comprising providing feedback to an electronic system for tracking at least one of the effectiveness of the procedure or proper performance of the surgical instrument.

9. The method according toclaim 2, wherein the surgical instrument is a surgical stapler.

10. A method of performing a surgical procedure comprising:

providing a surgical instrument having a pair of jaw members, at least one of the jaw members having a biosensor positioned on a tissue contacting surface thereof;

positioning tissue adjacent the biosensor;

measuring a physiologic parameter of the tissue using the biosensor;

determining, based on the measured physiologic parameter, whether the tissue is appropriate for a stapling procedure; and

conducting the stapling procedure if the determination is that the tissue is appropriate.

11. The method according toclaim 10 further comprising measuring a physiologic parameter of the tissue after the stapling procedure has been completed.

12. A method of performing a surgical procedure comprising:

providing a surgical instrument having a pair of jaw members, at least one of the jaw members having a biosensor positioned on a tissue contacting surface thereof;

identifying tissue to be subjected to a stapling procedure;

applying staples to the identified tissue;

positioning tissue adjacent the staples in operative proximity to the biosensor of the surgical instrument;

measuring a biological characteristic of the tissue using the biosensor; and

determining, based on the measured biologic characteristic, whether the tissue is viable or healthy.

13. The method ofclaim 12, further comprising measuring a biological characteristic of the identified tissue prior to applying staples.

14. A method of performing a surgical procedure, comprising:

positioning tissue between a pair of jaw members of a surgical instrument, at least one jaw member of the pair of jaw members having a biosensor;

applying at least one surgical fastener to the tissue;

measuring a biological characteristic of the tissue using the biosensor; and

determining, using the measured biological characteristic of the tissue, whether the tissue is healthy or viable.

15. The method ofclaim 14, wherein the surgical fastener is a surgical staple.

16. The method ofclaim 14, wherein the surgical instrument is a circular surgical stapler.

17. A method of performing a surgical procedure, comprising:

positioning tissue between a pair of jaw members of a surgical instrument, at least one jaw member of the pair of jaw members having a biosensor;

measuring a first biological characteristic of the tissue using the biosensor indicative of at least one of blood flow, blood presence, or blood pressure;

applying at least one surgical fastener to the tissue;

measuring a second biological characteristic of the tissue using the biosensor indicative of at least one of blood flow, blood presence, or blood pressure;

providing feedback to an electronic system for tracking at least one of the effectiveness of the procedure or proper performance of the surgical instrument.

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